Evaluation of HbA1c determination methods in patients with hemoglobinopathies.
Open accessAbstract
OBJECTIVE: To evaluate commercially available determination methods for HbA1c in patients with hemoglobin variants. RESEARCH DESIGN AND METHODS: HbA1c values were determined with various commercially available methods, including ion-exchange high-performance liquid chromatography (HPLC), boronate affinity assay, and immunoagglutination in patients with the hemoglobin mutations Hb Graz, Hb Sherwood Forest, Hb O Padova, Hb D, and Hb S. RESULTS: The effect of hemoglobinopathies on glycohemoglobin measurements was highly method dependent. The HPLC methods for HbA1c determination lacked the resolution necessary to differentiate hemoglobin variants. They demonstrated additional peaks in the chromatograms and HbA1c results either too low or too high compared with the nondiabetic reference range. With all immunoassays, Hb Graz demonstrated falsely low values. The other hemoglobinopathies in our study caused falsely low and/or high HbA1c results in immunoagglutination methods. The boronate affinity method showed values in an acceptable range for all hemoglobin variants. CONCLUSIONS: Because of the local occurrence of Hb variants and the ethnic origin of a given population, every individual laboratory must establish and validate its own assay method. In managing diabetic patients, knowledge of hemoglobinopathies influencing HbA1c determination methods is essential because hemoglobin variants could cause mismanagement of diabetes resulting from false HbA1c determinations.
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Several hemoglobin variants and chemically modified derivatives of hemoglobin interfere with some assay methods.
“Several hemoglobin variants (e.g., hemoglobins S, C, D, and E) and chemically modified derivatives of hemoglobin interfere with some assay methods (independent of any effects due to shortened RBC survival) (348-350) (for a review, see reference 347).”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [348]
The Conclusions (section labeled “Schnedl and Associates”; page not provided) state that hemoglobin variants interfere with HbA1c methods, and the paper reports method-dependent results for Hb S and Hb D. Our copy does not establish interference from chemically modified hemoglobin derivatives or the cited examples Hb C and Hb E. (LLM, conf=0.87)
Experimental — accuracy not yet measuredSeveral hemoglobin variants and chemically modified hemoglobin derivatives interfere with some HbA1c assay methods independently of shortened erythrocyte survival.
“Several Hb variants (e.g., Hbs S, C, D, and E) and chemically modified Hb derivatives interfere with some assay methods [independently of any effects due to shortened erythrocyte survival (234-236); for a review, see (233)].”
From Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (2011) · cites this paper as [236]
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Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Kirkman, M. S., Lernmark, A., Metzger, B. E., & Nathan, D. M. (2011) · Clinical Chemistry · doi:10.1373/clinchem.2010.161596 · Cited by 1,360 · see citing works
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Kirkman, M. S., Lernmark, A., Metzger, B. E., & Nathan, D. M. (2011) · Diabetes Care · doi:10.2337/dc11-9998 · Cited by 718 · see citing works
Goldstein, D. E., Little, R. R., Lorenz, R. A., Malone, J. I., Nathan, D., Peterson, C. M., & Sacks, D. B. (2004) · Diabetes Care · doi:10.2337/diacare.27.7.1761 · Cited by 625 · see citing works
Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin
Bry, L., Chen, P. C., & Sacks, D. B. (2001) · Clinical Chemistry · doi:10.1093/clinchem/47.2.153 · Cited by 523 · see citing works
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Lernmark, Å., Metzger, B. E., Nathan, D. M., & Kirkman, M. S. (2023) · Diabetes Care · doi:10.2337/dci23-0036 · Cited by 351 · see citing works
- Authors
- Schnedl, W. J., Krause, R., Halwachs-Baumann, G., Trinker, M., Lipp, R. W., & Krejs, G. J.
- Affiliations
- University of Graz (AT)
- Department of Internal Medicine, Karl-Franzens University, Graz, Austria. wolfgang.schnedl@kfunigraz.ac.at
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2000-03-01
- Volume
- 23
- Issue
- 3
- Pages
- 339-344
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2125878545
- Cited by
- 122
- References
- 0
- Citations by year
- 2025: 2 · 2024: 4 · 2023: 7 · 2022: 1 · 2021: 5 · 2020: 4 · 2019: 2 · 2018: 4 · 2017: 4 · 2016: 6 · 2015: 5 · 2014: 2 · 2013: 6 · 2012: 4
- FWCI
- 4.53
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Genetics › Hemoglobinopathies and Related Disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- HbA1c testing, hemoglobin variants, hemoglobinopathies, HbS, ion-exchange HPLC, assay validation, diabetes management
- MeSH terms
- Blood Chemical Analysis, Chromatography, High Pressure Liquid, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hemoglobinopathies, Hemoglobins, Abnormal, Humans, Biomarkers, Fructosamine
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